The MS Society has expressed disappointment that the National Institute for Health and Care Excellence (NICE) says it is “minded to say no” to recommending the use of Biogen Idec’s Tecfidera (dimethyl fumarate) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) on the NHS in England and Wales.

NICE has put out a draft guideline for consultation until March 12, and has asked Biogen Idec to supply it with “a series of clarifications,” also by that date.

When reviewing the evidence for Tecfidera, NICE’s independent appraisal committee had concluded that there were still questions to be asked about the clinical and cost-effectiveness for the drug for adults with RRMS, commented NICE chief executive Sir Andrew Dillon.

“This is why we have requested more details from the manufacturer – we want to ensure that we have as much information as possible to make an informed final recommendation,” he said.

Nick Rijke, director of policy and research at the MS Society, described this initial decision as “disappointing,” but added: “we’ve been here before for other MS treatments and seen the NICE decision overturned, so we’re hopeful to see a repeat of that.”

The Society will be offering its feedback and encouraging NICE to reverse its negative decision, he said, and pointed out that people with MS can also independently offer their feedback.

“This treatment is proven to be safe and effective in treating MS and we’re appealing to NICE to make it freely available on the NHS,” said Mr Rijke. 

Tecfidera was licensed in the UK earlier this month for the treatment of RRMS. It is taken twice a day and is proven to cut relapse rates – it may also delay disability progression, says the Society.

It also points out that Tecfidera is one of three treatments for RRMS currently going through European licensing and the NICE appraisal process.  A further treatment, Sanofi/Genzyme’s Aubagio (teriflunomide), was licensed and approved by NICE in January this year, after the Institute issued an initial negative decision.

The other two drugs are Sanofi’s Lemtrada (alemtuzumab), for which NICE is expected to give a final decision within the next few months, and Teva/Active Biotech’s Nerventra (laquinimod), which the MS Society hopes will be licensed and then reviewed by NICE later this year.

NICE says it expects to publish final guidance on the use of Tecfidera in RRMS this summer.

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